A Xarelto bleeding lawsuit was filed against drug manufacturers Bayer Healthcare and Janssen Pharmaceuticals alleging they failed to provide adequate warnings about the safety risks associated with the use of the popular blood thinner.

A Texas resident alleges the companies failed to warn patients and provide information to physicians related to the increased risks of internal bleeding events associated with taking Xarelto. According to the Xarelto lawsuit, plaintiff Rita O. used Xarelto beginning in March 2012 to treat deep vein thrombosis.

She subsequently experienced a gastrointestinal bleed, for which she was hospitalized in March 2013, as well as other life-threatening severe and personal injuries that were allegedly due to Bayer and Janssen’s failure to include a “Boxed Warning” about Xarelto bleeding.

Rita claims the drug should not be sold and that Bayer and Janssen negligently promoted Xarelto as safe when they allegedly knew the blood thinner could cause life-threatening gastrointestinal bleeding. Rita is also seeking for her Xarelto lawsuit to be included in the multidistrict litigation currently pending in the U.S. District Court for the Eastern District of Louisiana [In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL 2592, Case No. 14-md-2592].

Xarelto Bleeding Events

Xarelto (rivaroxaban) was first approved by the FDA in July of 2011 as a prescription medicine with three primary uses: to reduce the risk of blood clots and stroke in patients with atrial fibrillation, to treat deep vein thrombosis and pulmonary embolism, and to reduce the risk of blood clots in patients undergoing knee or hip replacement surgery.

Xarelto belongs to a class of anticoagulants called direct factor Xa inhibitors. Sometimes referred to as blood thinners, anticoagulants interfere with the normal clotting of the blood.

Clotting is essential if a person is to stop bleeding from an open wound, but some people experience clotting when they are not injured. Atrial fibrillation is a heart condition characterized by an irregular heartbeat that can cause blood to pool in the heart and may lead to clots.

If these travel to the brain, they may cause a stroke. Blood clots that develop in the legs (deep vein thrombosis) and pulmonary embolism (blood clots in the lungs) can cause serious complications and/or death if left untreated.

When people experience side effects they suspect were caused by a prescription or over-the-counter medicine, they or their doctors may report the events to the FDA. These events are recorded in the FDA Adverse Events Reporting System (AERS).

Of the more than 1,800 adverse events linked to Xarelto, the most common events were pulmonary embolism (386 reports), deep vein thrombosis (279 reports), gastrointestinal hemorrhage (107 reports) and hemorrhage (107 reports). Hospitalization was reported in 891 of these events; and 183 of the patients lost their lives.

Xarelto Injury Lawsuits

The Xarelto injury lawsuit is seeking compensatory, economic, and punitive damages for the drug companies’ alleged fraudulent and reckless disregard for the safety and welfare of Xarelto users like Rita.

The Xarelto Lawsuit is Case No. 1:15-cv-00180 in the U.S. District Court for the Western District Texas, Austin Division and the Xarelto MDL is Case No. 14-md-2592, In re: Xarelto (Rivaroxaban) Products Liability Litigation,  in the U.S. District Court for the Eastern District of Louisiana.